NCT02300558

Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3

A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects With Long QT Syndrome Type 3

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (OLE) phase.

Conditions

• Long QT Syndrome Type 3

Interventions

Type	Name	Description
DRUG	Eleclazine	Tablets administered orally
DRUG	Eleclazine placebo	Tablets administered orally

Timeline

• Start date: 2014-12-17
• Primary completion: 2016-12-12
• Completion: 2017-02-15
• First posted: 2014-11-25
• Last updated: 2018-01-12
• Results posted: 2018-01-12

Locations

12 sites across 8 countries: United States, Canada, France, Germany, Israel, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study